SPS-Q2
An Open Label Individual Patient Dose Escalation Study Investigating the Safety and Efficacy of Retreatment With GCAR1 in a Patient With Multiply Relapsed Alveolar Soft Part Sarcoma
Sponsor study identifier
Secondary identifiers
OTHER · Health Research Ethics Board of Alberta
interventional
1
1 country
1
Study Start
January 30, 2025
Actual (reported)Primary Completion
January 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A single patient study to determine whether GCAR1 is safe and effective for re-treatment of alveolar soft part sarcoma (ASPS) with GPNMB surface expression that has relapsed and is not responding to usual treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 28, 2025
Actual (reported)January 30, 2025
Actual (reported)February 7, 2025
Actual (reported)January 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Treatment Response
The overall response assessment considers the response of the target and non-target lesions and development of new lesions. Response Classification of Target Lesions, CNS lesions and Non-Target Lesions * Complete response (CR): * Partial response (PR): * Progressive disease (PD): * Stable disease (SD):
Diagnostic imaging (CT and/or MRI) will be performed at baseline (pre-treatment) and then subsequently at 4-6 weeks after GCAR1 infusion, and at 3 months, 6 months, 9 months and 1 year after last infusion to evaluate response to therapy.
This is an intrapatient two-dose escalation study. The patient will receive two separate intravenous infusions of cryopreserved, autologous GCAR1, with at least three months (+/- 30 days) between infusions. Both infusions will be preceded by standard lymphodepleting chemotherapy (Fludarabine 40 mg/m2 x 3 days, cyclophosphamide 600 mg/m2 x 2 days) . Dose 1 will be 5.0E6 CAR+ T cells/kg patient body weight, Dose 2 will be 2.5E7 CAR+ T cells/kg patient body weight. Infusions will be intravenous, single infusions.
GCAR1 is a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector encoding a chimeric antigen receptor (CAR) targeting GPNMB. The CAR comprises a single-chain variable fragment (scFv) binding domain derived from a fully human GPNMB-specific monoclonal antibody (CDX-011), a CD8 hinge and transmembrane domain, and the CD137 (4-1BB) and CD3 zeta chain intracellular signaling domains. Following infusion, the autologous GPNMB CAR T-cells expressing the genetically engineered anti-GPNMB CAR enable the specific targeting of GPNMB-expressing cells. Upon binding to GPNMB-expressing cells, the CAR transmits T cell activation signals that promote the elimination of target cells through CAR T cell degranulation and the release of cytotoxic molecules. The cellular signal also facilitates CAR T cell proliferation and persistence that may enable prolonged disease control through immunosurveillance3.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
1 participants (actual enrollment reported by the registry).
First Submitted
January 28, 2025
First Posted
February 7, 2025
Study Start
January 30, 2025
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
January 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 10, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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